PROJECT SUMMARY/ABSTRACT The Biostatistics and Bioinformatics Shared Resource Facility (BB SRF) is an essential cancer center- managed resource and has played a critical role as members in team science by providing statistical and bioinformatics expertise to enable and enhance the Markey Cancer Center?s (MCC) basic, clinical and population research. BB SRF services are categorized broadly into: 1) study planning, power and sample size calculations for grant applications; 2) design and implementation support for clinical trials; 3) statistical analyses, including interim and final analysis for the entire spectrum of cancer research studies; 4) bioinformatics methods for design and analysis of high-throughput ?omics data; 5) statistical programming for data quality control and data processing; and 6) mentoring, education and general consultation to MCC investigators. BB SRF services are coordinated with other MCC SRFs with hand-offs and integrated workflows to ensure comprehensive, seamless and non-overlapping support. During the current funding cycle, the BB SRF has made significant scientific impact by employing technical methodologies directly supporting MCC Research Program themes. These technical methodologies include development and implementation of state- of-the-art data processing and data analysis pipelines and software for several genomic platforms with specific applications to Kentucky?s Appalachian population; novel differential analysis and classification methodologies for metabolomics and exosome data for lung, breast and pancreas cancers; adaptive and model-based dose finding designs and state-of-the art designs for early phase trials with biomarker and genomic evaluations of targeted therapies; statistical methodologies for population-based cancer prevention studies including nonparametric estimation and hypothesis testing of risk factor distributions, relative survival estimation and statistical methods for cancer registry and large claims databases to support research in MCC?s research in health disparities. In addition to support as co-investigators in 52 newly funded grants and over 40 investigator- initiated trials, BB SRF faculty engaged in novel methodological work to enhance the science of MCC Research Programs. During the current CCSG funding cycle, the BB SRF supported 128 MCC members (81 peer-reviewed funded) from all 4 MCC Research Programs, representing 74% coverage from the total MCC membership. The BB SRF has significantly increased usage and value added metrics, expanded its services and has grown in personnel from 8 faculty and staff to a current total of 14 to address the growth and emerging research directions of the MCC. The highly experienced personnel and diverse skill set of the BB SRF adds significant value to the execution of scientifically rigorous research at the MCC and demonstrates that the BB SRF is well positioned to support the MCC as a Comprehensive Cancer Center for the Commonwealth of Kentucky in this renewal application.